FS TEST KIT
Device Facts
| Record ID | K854015 |
|---|---|
| Device Name | FS TEST KIT |
| Applicant | American Bioproducts Co. |
| Product Code | JBN · Hematology |
| Decision Date | Mar 6, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7300 |
| Device Class | Class 2 |
Regulatory Classification
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document.
